World of DTC Marketing

OCTOBER 6, 2021

to produce, according to a report issued last week by drug pricing experts at the Harvard School of Public Health and King’s College Hospital in London. Remdesivir was the first drug approved by the Food and Drug Administration to treat COVID-19. And while it costs $17.74 Merck charges the U.S.

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

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Pharma Food and Drug Administration Marketing Prescription 210

World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). Then there is the cost of generic drugs. bil­lion in 2020 if it had pur­chased 77 of 89 drugs from Cuban’s firm.

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Healthcare Healthcare Food and Drug Administration FDA 227

Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

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Food and Drug Administration FDA Food Patients 105

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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Food and Drug Administration FDA Physicians Food 52

European Pharmaceutical Review

OCTOBER 9, 2022

QBiotics, a biotech firm in Australia, initially identified tigilanol tiglate as potentially useful for drug development. To develop the drug, researchers used a Chinese herbal medicine called Croton tiglium (purging croton), which has an active pharmaceutical ingredient (API) called phorbol.

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Food and Drug Administration Medicine Food Pharmaceutical 132

European Pharmaceutical Review

JANUARY 29, 2024

In reviewing both the revised ISO standard and FDA study discussed, it is clear robust evaluation of toxicological substances such as extractables and leachables remain a key part of device-drug combination product and medical device safety assessments.

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Food and Drug Administration Medical Safety Food 83

European Pharmaceutical Review

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. It has also outlined the various issues impacting on the drug product.

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Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). dL) for the patients.

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Food and Drug Administration FDA Safety Food 105

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals.

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Food and Drug Administration FDA Biopharma Food 52

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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Food and Drug Administration Manufacturing Food Medicine 87

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. AML makes up 23.1%

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Food and Drug Administration FDA Safety Prescription 98

World of DTC Marketing

APRIL 7, 2021

million compensation package in 2020, a slight increase from his $19.6 Pfizer CEO Bourla’s Pay Climbed 17% to $21 Million in 2020 and Gilead Sciences CEO Daniel O’Day earned a $19 million take home. drug spending by 9 percent” What about taxpayers? Bob Bradway of Amgen bagged a $20.1 This has to end.

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European Pharmaceutical Review

AUGUST 11, 2023

Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA). Conditional marketing authorisation is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need.

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Marketing Food and Drug Administration Medicine FDA 86

Pharmaceutical Technology

MAY 5, 2023

In July 2020, the European Commission (EC) granted conditional marketing authorisation to bulevirtide for urgent access to HDV treatment. It has also received breakthrough therapy and orphan drug designations from the US Food and Drug Administration.

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Food and Drug Administration Marketing Medicine Food 59

Pharma Leaders

JUNE 27, 2023

Jesduvroq (daprodustat) tablets received approval from the US Food and Drug Administration (FDA) in February this year to treat CKD-caused anaemia in adults on dialysis for a minimum of four months.

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Food and Drug Administration Medicine Food Safety 52

Pharmaceutical Technology

JUNE 19, 2023

In 2020, both companies initially collaborated for Biomm’s distribution and marketing of Bio-Thera’s bevacizumab biosimilar, BAT1706, in Brazil. It plans to seek regulatory approval from the European Medicines Agency, the China National Medical Products Administration and the US Food and Drug Administration.

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Food and Drug Administration Distribution Food Marketing 52

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

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Manufacturing Food and Drug Administration FDA Pharma 52

pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates. appeared first on.

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Food and Drug Administration Pharma Medicine Healthcare 78

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.

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Pharmaceutical Technology

MAY 3, 2023

Lupkynis has also received orphan drug designation in Switzerland. It is claimed to be the first oral medicine to receive approval from the US Food and Drug Administration and the European Commission to treat active LN in adults. This promotes podocyte stability in the kidneys.

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Food and Drug Administration Marketing Food Pharmaceutical 52

Pharmaceutical Technology

FEBRUARY 6, 2023

The first-in-class orally available investigational drug, Telacebec blocks Mycobacterium tuberculosis growth by inhibiting cytochrome bc1 complex. In preclinical and clinical studies, the drug showed potent efficacy against drug-sensitive and drug-resistant TB.

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Food and Drug Administration Food Medicine FDA 59

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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European Pharmaceutical Review

AUGUST 16, 2022

HCC accounted for more approximately 85 percent of the 900,000 new liver cancer cases in 2020, according to the Globocan 2020 database. . Following this trial, in September 2021 the US Food and Drug Administration accepted a Biologics License Application (BLA) from BeiGene on behalf of Novartis in the US.

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Food and Drug Administration Patients Safety Food 98

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc., the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S.

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Pharmaceutical Technology

MAY 10, 2023

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Farxiga (dapagliflozin) to reduce the risks of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) emergency care visits in HF adult patients.

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Food and Drug Administration FDA Food Patients 52

Pharmaceutical Technology

JANUARY 23, 2023

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. In 2020, fruquintinib received Fast Track designation from the US Food and Drug Administration (FDA) to treat metastatic CRC patients.

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Food and Drug Administration Medicine FDA Food 52

pharmaphorum

NOVEMBER 2, 2022

The most common solutions today for pain relief are non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, meaning that standard treatments have not changed for a number of years. The problem is that opioids do not work in the long-term, and this has led to a search for alternatives. The potential for a digital solution.

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Food and Drug Administration Food FDA Patients 124

Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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Food and Drug Administration Physicians Competition FDA 59

Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. It was also granted Orphan Drug Designation during the same time.

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Food and Drug Administration FDA Food Safety 52

pharmaphorum

NOVEMBER 27, 2022

This follows the initial licence for treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in 2020. Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster. It is coordinated by the US Food and Drug Administration (FDA).

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Food and Drug Administration Medicine Consulting Patients 77

Pharmaceutical Technology

AUGUST 28, 2022

Moderna pledged not to impose its Covid-19-related patents in October 2020 in a bid to provide equitable access across the globe. The latest development comes after Moderna sought emergency use authorization from the US Food and Drug Administration for its BA.4/BA.5

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Pharmaceutical Technology

APRIL 26, 2023

in December 2022, the digital therapy, called CT-132, secured a Breakthrough Device designation from the US Food and Drug Administration (FDA) as an adjunctive preventive treatment for episodic migraine in patients above the age of 18 years. Its use is especially applicable in mental health and neurology.

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Food and Drug Administration Pharmacology Food Patients 52

European Pharmaceutical Review

AUGUST 11, 2022

The study compared outcomes for 110 patients treated with remdesivir and dexamethasone and 81 treated with both those medications plus baricitinib at Saint Peter’s University Hospital in New Jersey, USA, between June 2020 and June 2021. .

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Food and Drug Administration Patients Medical Food 75